This document provides guidance on temperature and humidity monitoring systems for transport operations of time and temperature sensitive pharmaceutical products. It describes various device types for monitoring temperature and humidity during transport. The key types discussed are electronic data loggers and indicators. It emphasizes the importance of monitoring to ensure pharmaceutical quality and notes regulatory authorities may require documented evidence. Shippers are responsible for ensuring temperature compliance during transport using monitoring devices and agreements with carriers on device use and data collection/storage.
This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems in accordance with the Kyoto Protocol. The document provides recommendations for installation, maintenance, decommissioning of equipment, and training of staff to ensure proper handling of refrigerants.
The document provides guidance on transport route profiling qualification to ensure time and temperature sensitive pharmaceutical products are maintained within acceptable temperature ranges during distribution. It describes conducting studies using data loggers placed in sample shipments to collect temperature data over multiple routes and seasons. The degree-hour concept is introduced to analyze temperature exposures. Methods are presented for using the profile data to design packaging solutions or assess the suitability of passive container designs for different routes and climates.
This document provides guidance on the maintenance of refrigeration equipment used for storing and transporting temperature sensitive pharmaceutical products. It covers the maintenance needs for refrigerators, freezers, cold rooms, refrigerated vehicles, containers, and associated equipment. The guidance addresses inspection schedules, maintaining cooling systems, insulation, seals, and other aspects. Proper maintenance is important for ensuring refrigeration equipment functions as intended to keep products within required temperature ranges during storage and transport.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses requirements for such systems including automated continuous monitoring, data collection via wireless or wired transmission, alarm systems, and adaptability. The guidance covers factors like maintenance needs, number and location of monitoring points, and post-installation qualification activities.
This document provides guidance on how to conduct a temperature mapping study of a temperature-controlled storage area. It describes a 4-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise using electronic data loggers, 3) analyzing the data and preparing a report, and 4) implementing recommendations from the report. The mapping establishes the temperature distribution and identifies hot/cold spots to ensure products are stored correctly. It helps determine if changes are needed to eliminate temperature issues.
Supplement 7- Annex9- WHO guideline: Qualification of temperature controlled storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on selecting suitable sites for storage facilities for time and temperature sensitive pharmaceutical products. Key factors to consider include:
- Choosing a site that minimizes risks from natural hazards like floods, fires, and weather events.
- Locating the site to efficiently serve the target population using existing transport infrastructure.
- Establishing the required size of the warehouse before searching for sites.
- Narrowing down choices using local knowledge and online tools to evaluate potential sites.
- Choosing a secure site in a low crime area with good emergency response times.
- Selecting a site that allows for future expansion and has access to major transport routes.
- Ensuring the site has low risks of
This document provides guidance on maintaining storage buildings used for pharmaceutical products. It discusses the importance of maintenance for protecting assets and outlines different types of maintenance activities. The document emphasizes establishing preventative maintenance programs and schedules during building design and construction to minimize corrective maintenance needs long-term. Guidance is provided on creating operation and maintenance manuals and health and safety files to document building information for effective maintenance management.
This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems in accordance with the Kyoto Protocol. The document provides recommendations for installation, maintenance, decommissioning of equipment, and training of staff to ensure proper handling of refrigerants.
The document provides guidance on transport route profiling qualification to ensure time and temperature sensitive pharmaceutical products are maintained within acceptable temperature ranges during distribution. It describes conducting studies using data loggers placed in sample shipments to collect temperature data over multiple routes and seasons. The degree-hour concept is introduced to analyze temperature exposures. Methods are presented for using the profile data to design packaging solutions or assess the suitability of passive container designs for different routes and climates.
This document provides guidance on the maintenance of refrigeration equipment used for storing and transporting temperature sensitive pharmaceutical products. It covers the maintenance needs for refrigerators, freezers, cold rooms, refrigerated vehicles, containers, and associated equipment. The guidance addresses inspection schedules, maintaining cooling systems, insulation, seals, and other aspects. Proper maintenance is important for ensuring refrigeration equipment functions as intended to keep products within required temperature ranges during storage and transport.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses requirements for such systems including automated continuous monitoring, data collection via wireless or wired transmission, alarm systems, and adaptability. The guidance covers factors like maintenance needs, number and location of monitoring points, and post-installation qualification activities.
This document provides guidance on how to conduct a temperature mapping study of a temperature-controlled storage area. It describes a 4-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise using electronic data loggers, 3) analyzing the data and preparing a report, and 4) implementing recommendations from the report. The mapping establishes the temperature distribution and identifies hot/cold spots to ensure products are stored correctly. It helps determine if changes are needed to eliminate temperature issues.
Supplement 7- Annex9- WHO guideline: Qualification of temperature controlled storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on selecting suitable sites for storage facilities for time and temperature sensitive pharmaceutical products. Key factors to consider include:
- Choosing a site that minimizes risks from natural hazards like floods, fires, and weather events.
- Locating the site to efficiently serve the target population using existing transport infrastructure.
- Establishing the required size of the warehouse before searching for sites.
- Narrowing down choices using local knowledge and online tools to evaluate potential sites.
- Choosing a secure site in a low crime area with good emergency response times.
- Selecting a site that allows for future expansion and has access to major transport routes.
- Ensuring the site has low risks of
This document provides guidance on maintaining storage buildings used for pharmaceutical products. It discusses the importance of maintenance for protecting assets and outlines different types of maintenance activities. The document emphasizes establishing preventative maintenance programs and schedules during building design and construction to minimize corrective maintenance needs long-term. Guidance is provided on creating operation and maintenance manuals and health and safety files to document building information for effective maintenance management.
This document provides guidance on estimating the storage capacity needs for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It outlines key concepts for inventory management that are important for accurately determining storage requirements, such as safety stock levels, product classification systems, and ideal inventory control models. The document also describes the types of product and storage data that should be collected, such as unit volumes, temperature storage needs, and security classifications. This information is critical for properly sizing pharmaceutical warehouses and ensuring adequate cold storage capacity is available within facilities.
This document provides guidance on estimating the storage capacity requirements for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It covers how to collect product data, calculate maximum inventory volumes, and determine the net storage capacity needed based on factors like storage temperature, security classification, and load support systems. The target audience is organizations planning new or expanded storage facilities for vaccines and other medical products.
This document provides guidance on designing storage facilities for time and temperature sensitive pharmaceutical products (TTSPPs). It discusses key considerations like environmental auditing, low-carbon design, and warehouse layouts. Regarding layouts, it describes the main types - U-flow and through-flow arrangements. It emphasizes designing for flexibility and efficiency to accommodate future changes. The target is to help readers act as informed clients when procuring medical warehouses and related facilities.
This document provides guidance on qualifying temperature-controlled storage areas according to good storage practices. It outlines the requirements and objectives of qualification, which involves three stages: installation qualification (IQ) to confirm proper installation, operational qualification (OQ) to confirm operation under controlled conditions, and performance qualification (PQ) to confirm performance under routine conditions. The document provides detailed guidance on conducting each stage of qualification, including procedures, acceptance criteria, and documentation requirements.
This document provides guidance on designing storage facilities for pharmaceutical products, including warehouses and dispensing facilities. It covers preparing a design brief, appointing a design team, choosing a procurement process, and roles during construction and commissioning. The guidance aims to help readers act as informed clients for procuring medical storage facilities. Specific topics covered include low-carbon design, warehouse layouts, temperature-controlled storage areas, and procuring cold rooms and freezers.
This document provides guidance on building security, fire prevention, detection and management for buildings used to store time and temperature sensitive pharmaceutical products (TTSPPs). It recommends perimeter security fencing, controlled access points, intruder alarms, fire detection systems, sprinklers, staff training and fire drills. Specific guidance is given for secured storage of controlled substances, installation and maintenance of fire protection equipment, and fire risk management procedures. The aim is to prevent unauthorized access, theft and fires in premises storing these thermo-labile medical products.
This document provides guidance on conducting temperature mapping of storage areas. It describes developing a detailed mapping protocol, carrying out the mapping exercise using data loggers, analyzing the results to identify hot/cold spots and temperature variations, and implementing recommendations. The objective is to document temperature distribution within storage areas to ensure time- and temperature-sensitive pharmaceutical products are stored correctly. Developing a comprehensive temperature map establishes storage zone requirements and identifies areas needing remedial action.
Hdbs15, phụ lục 9 gmp who, hệ thống theo dõi nhiệt độ độ ẩm trong khi vận chuyểnTư vấn GMP, cGMP, ISO
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices, including device types like electronic data loggers and indicators. It also covers data collection, storage and retrieval from these monitoring devices. The target readership are those involved in the transport and distribution of time- and temperature-sensitive pharmaceutical products.
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices used to track temperature and humidity during transport of pharmaceuticals. It covers different types of monitoring devices including electronic data loggers and indicators. It provides guidance on selecting appropriate monitoring devices and ensuring proper data collection, storage and retrieval.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses key considerations for selecting a monitoring system such as preparing requirements, choosing between automated continuous or data logging systems, wireless vs wired data transmission, alarm systems, and expandability. The document also covers maintenance, number of monitoring points, deploying the system, and qualification activities.
This document provides guidance on conducting temperature mapping of storage areas. It outlines a four-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise, 3) preparing a mapping report, and 4) implementing recommendations from the report. The guidance details what should be included in the mapping protocol, such as objectives, methodology, and a report template. It also describes the materials and equipment needed, including electronic data loggers, and how to analyze temperature data and interpret results.
The document provides guidance on maintenance of storage facilities for time and temperature sensitive pharmaceutical products. It discusses the importance of maintenance and outlines best practices for maintenance management, including establishing frameworks, developing preventative maintenance schedules, conducting periodic inspections, and organizing maintenance work. The document is intended to help facilities properly maintain storage infrastructure to ensure products are stored under appropriate environmental conditions.
This document provides guidance on selecting refrigerants and blowing agents for refrigeration equipment to minimize environmental impact, in accordance with the Montreal Protocol and efforts to reduce greenhouse gas emissions. It recommends phasing out ozone-depleting substances like CFCs and transitioning to alternatives with lower global warming potential, such as hydrocarbons for small systems and hydrofluoroolefins as they become available. Proper installation, maintenance, and disposal of equipment is advised to prevent refrigerant leakage into the atmosphere.
Hdbs16,phụ lục 9 gmp who, kiểm soát ảnh hưởng đến môi trường của các thiết bị...Tư vấn GMP, cGMP, ISO
This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems and proper installation, maintenance, and staff training practices. The target audience includes organizations operating refrigeration equipment used for storage and transport of temperature sensitive products.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
This document provides guidance on estimating the storage capacity needs for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It outlines key concepts for inventory management that are important for accurately determining storage requirements, such as safety stock levels, product classification systems, and ideal inventory control models. The document also describes the types of product and storage data that should be collected, such as unit volumes, temperature storage needs, and security classifications. This information is critical for properly sizing pharmaceutical warehouses and ensuring adequate cold storage capacity is available within facilities.
This document provides guidance on estimating the storage capacity requirements for facilities storing time and temperature sensitive pharmaceutical products (TTSPPs). It covers how to collect product data, calculate maximum inventory volumes, and determine the net storage capacity needed based on factors like storage temperature, security classification, and load support systems. The target audience is organizations planning new or expanded storage facilities for vaccines and other medical products.
This document provides guidance on designing storage facilities for time and temperature sensitive pharmaceutical products (TTSPPs). It discusses key considerations like environmental auditing, low-carbon design, and warehouse layouts. Regarding layouts, it describes the main types - U-flow and through-flow arrangements. It emphasizes designing for flexibility and efficiency to accommodate future changes. The target is to help readers act as informed clients when procuring medical warehouses and related facilities.
This document provides guidance on qualifying temperature-controlled storage areas according to good storage practices. It outlines the requirements and objectives of qualification, which involves three stages: installation qualification (IQ) to confirm proper installation, operational qualification (OQ) to confirm operation under controlled conditions, and performance qualification (PQ) to confirm performance under routine conditions. The document provides detailed guidance on conducting each stage of qualification, including procedures, acceptance criteria, and documentation requirements.
This document provides guidance on designing storage facilities for pharmaceutical products, including warehouses and dispensing facilities. It covers preparing a design brief, appointing a design team, choosing a procurement process, and roles during construction and commissioning. The guidance aims to help readers act as informed clients for procuring medical storage facilities. Specific topics covered include low-carbon design, warehouse layouts, temperature-controlled storage areas, and procuring cold rooms and freezers.
This document provides guidance on building security, fire prevention, detection and management for buildings used to store time and temperature sensitive pharmaceutical products (TTSPPs). It recommends perimeter security fencing, controlled access points, intruder alarms, fire detection systems, sprinklers, staff training and fire drills. Specific guidance is given for secured storage of controlled substances, installation and maintenance of fire protection equipment, and fire risk management procedures. The aim is to prevent unauthorized access, theft and fires in premises storing these thermo-labile medical products.
This document provides guidance on conducting temperature mapping of storage areas. It describes developing a detailed mapping protocol, carrying out the mapping exercise using data loggers, analyzing the results to identify hot/cold spots and temperature variations, and implementing recommendations. The objective is to document temperature distribution within storage areas to ensure time- and temperature-sensitive pharmaceutical products are stored correctly. Developing a comprehensive temperature map establishes storage zone requirements and identifies areas needing remedial action.
Hdbs15, phụ lục 9 gmp who, hệ thống theo dõi nhiệt độ độ ẩm trong khi vận chuyểnTư vấn GMP, cGMP, ISO
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices, including device types like electronic data loggers and indicators. It also covers data collection, storage and retrieval from these monitoring devices. The target readership are those involved in the transport and distribution of time- and temperature-sensitive pharmaceutical products.
The document is a technical supplement from the WHO on temperature and humidity monitoring systems for transport operations. It discusses requirements for monitoring devices used to track temperature and humidity during transport of pharmaceuticals. It covers different types of monitoring devices including electronic data loggers and indicators. It provides guidance on selecting appropriate monitoring devices and ensuring proper data collection, storage and retrieval.
The document provides guidance on choosing and implementing temperature and humidity monitoring systems for fixed storage areas. It discusses key considerations for selecting a monitoring system such as preparing requirements, choosing between automated continuous or data logging systems, wireless vs wired data transmission, alarm systems, and expandability. The document also covers maintenance, number of monitoring points, deploying the system, and qualification activities.
This document provides guidance on conducting temperature mapping of storage areas. It outlines a four-stage process: 1) preparing a mapping protocol, 2) carrying out the mapping exercise, 3) preparing a mapping report, and 4) implementing recommendations from the report. The guidance details what should be included in the mapping protocol, such as objectives, methodology, and a report template. It also describes the materials and equipment needed, including electronic data loggers, and how to analyze temperature data and interpret results.
The document provides guidance on maintenance of storage facilities for time and temperature sensitive pharmaceutical products. It discusses the importance of maintenance and outlines best practices for maintenance management, including establishing frameworks, developing preventative maintenance schedules, conducting periodic inspections, and organizing maintenance work. The document is intended to help facilities properly maintain storage infrastructure to ensure products are stored under appropriate environmental conditions.
This document provides guidance on selecting refrigerants and blowing agents for refrigeration equipment to minimize environmental impact, in accordance with the Montreal Protocol and efforts to reduce greenhouse gas emissions. It recommends phasing out ozone-depleting substances like CFCs and transitioning to alternatives with lower global warming potential, such as hydrocarbons for small systems and hydrofluoroolefins as they become available. Proper installation, maintenance, and disposal of equipment is advised to prevent refrigerant leakage into the atmosphere.
Hdbs16,phụ lục 9 gmp who, kiểm soát ảnh hưởng đến môi trường của các thiết bị...Tư vấn GMP, cGMP, ISO
This document provides guidance on environmental management of refrigeration equipment. It discusses requirements under the Montreal Protocol for selecting refrigerants with low ozone depletion potential. It also addresses reducing carbon dioxide emissions from refrigeration systems and proper installation, maintenance, and staff training practices. The target audience includes organizations operating refrigeration equipment used for storage and transport of temperature sensitive products.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
This document from the WHO provides guidance on selecting sites for pharmaceutical storage facilities. It discusses factors to consider such as establishing the required warehouse size, choosing a secure site, future-proofing the site, and ensuring labor availability. A site investigation process is outlined to identify risks and opportunities, including assessing ground conditions, underground/overhead services, and environmental impacts. Logistics network planning principles are also briefly covered, emphasizing the need to optimize distribution networks through factors like population distribution, transport infrastructure, and inventory/transport costs.
Tài liệu GMP được chia sẻ bởi GMPc Việt Nam - Nhà tư vấn Sáng tạo, Chuyên nghiệp, Toàn diện Dự án Nhà máy GMP (EU, PIC/S, WHO, ASEAN), ISO 13485:2012, ISO/IEC 17025:2005, ISO 15189:2012, ISO 15378:2011, ISO 9001:2008
O documento lista os artilheiros e seus gols marcados em várias copas regionais no Rio Grande do Sul, incluindo a Copa Metropolitana, Copa Região Sul-Fronteira, e Copa Região Serrana. Maicon Santana da equipe Cerâmica foi o maior artilheiro com 6 gols, enquanto Hyantony do Passo Fundo marcou 11 gols na Copa Região Serrana. Várias equipes e jogadores são listados com seus respectivos gols marcados.
This document summarizes downsizing theory and discusses Hewlett-Packard's history with downsizing. It provides an overview of why companies downsize, common downsizing strategies, and potential positive and negative outcomes. It then discusses HP's circumstances, including acquiring other companies and needing to simplify its HR system. HP underwent major layoffs in 2005 and 2008 to cut costs during an economic crisis. The document analyzes advantages and disadvantages of HP's actions and recommends identifying redundant jobs and considering alternatives to layoffs.
Corporate social responsibility of Jubilantkirti sharma
This document provides a summary of a company's profile, board of directors, corporate social responsibility focus areas and activities. The company is an integrated global pharmaceutical and life sciences company serving customers in over 100 countries. It has a strong R&D team and modern facilities. The company's CSR focuses on healthcare, education and livelihood programs carried out near its manufacturing locations. Key CSR activities include supporting quality education in rural schools, reducing infant/maternal mortality through health centers, and providing vocational training for livelihood opportunities.
Este documento discute conceptos clave relacionados con la planificación y gestión del tiempo en proyectos. Explica leyes como la de Murphy y Parkinson que pueden afectar el cumplimiento de plazos, así como el síndrome del estudiante. También define restricciones como factores que limitan el logro de objetivos y discute cómo identificar y tratar con la ruta crítica para evitar atrasos.
O autor processou a empresa construtora por atraso na entrega de um imóvel adquirido. A ré alega que não houve atraso e que o autor não se mudou por outros motivos. O juiz decidirá se a ré deve indenizar o autor pelos custos com aluguel durante o período de atraso alegado.
Documentación para p. residencia y trabajoEmagister
La documentación necesaria que una empresa debe presentar para solicitar un permiso de residencia y trabajo para un inmigrante en Extremadura incluye: los TC1 y TC2 de los últimos tres meses de la empresa, documentos que acrediten los pagos a la Seguridad Social y Hacienda, fotocopias del DNI del empresario y escrituras o documentación de la empresa, una oferta de empleo debidamente cumplimentada, el CIF de la empresa e impuestos del año pasado y, si procede, los estatutos o comunidad de bienes de la
Laure Maillard- Financing social housing in France #housingfinanceHousing Europe
1. Financing for social housing in France comes primarily from loans through the country's Savings Fund (73%), which collects savings from passbook accounts and transforms them into long-term, low-interest loans for social housing and other community projects.
2. The Savings Fund model allows for very long-term financing at preferred rates through a single pricing policy, with loans often granted at or below the resource cost for social and environmentally-focused housing.
3. This dedicated funding source proved resilient during the financial crisis, ensuring a steady supply of long-term loans to social housing providers when credit was constrained elsewhere.
Un excelente diccionario basado en los trabajos de Freire y su vision humanista, biografía y mucho más, que te ayudará a comprender el problema ducativo de America Latina y sus posibilidades transformativas.
Why Teaching is the Most Important Profession?Deah Galas
Teaching is the most important profession because teachers have the ability to profoundly influence students and shape their futures. Several studies have shown that teachers have significant impacts on student achievement, attendance at college, future earnings, and other life outcomes. Good teachers can improve student performance while poor teachers can negatively affect students. The work of teachers is crucial for building the next generation and developing the leaders and workforce of the future.
Supplement 8- Annex9- WHO guideline: Temperature mapping of storage areas
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
This document provides guidance on conducting temperature mapping of storage areas to document temperature distribution and identify hot and cold spots. It outlines developing a detailed mapping protocol, carrying out the study using electronic data loggers, analyzing the results to determine minimum, maximum and mean temperatures, and making recommendations to address any issues identified. The goal is to ensure time- and temperature-sensitive pharmaceutical products are stored within their specified temperature ranges.
Supplement 6- Annex9- WHO guideline: Temperature and humidity monitoring systems
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
The document provides guidance on transport route profiling qualification for time and temperature sensitive pharmaceutical products. It outlines how to conduct a transport route study using data loggers, retrieve temperature data, analyze the data using degree-hour concepts, and organize the data to assess if packaging solutions maintain adequate temperature control along specific routes. The guidance aims to help qualify routes for known packaging by characterizing temperature exposures.
Role of Temperature Data Loggers and Monitor Vaccine Temperature from Start t...G-Tek Corporation
G-Tek offers a solution to monitor and track the temperature conditions of vaccines from start to finish as they are transported and stored within the cold chain. The devices log and stores data for comprehensive historical records and generates detailed reports. G-Tek vaccine temperature data logger provide reliable & affordable solution for monitoring environmental condition & maintaining quality of temperature responsive product.
G-Tek Electronic Shipping Indicators play a critical role in maintaining vaccines safety during transit by monitoring and recording temperature data and providing visual alerts for temperature breaches. These indicators are essential, as they provide the necessary evidence of vaccine safety that pharmaceutical companies and supply chain managers require-certifying vaccine safety and efficacy.
Supplement 4- Annex9- WHO guideline: Maintenance of storage facilities
Technical supplement to WHO Technical Report Series, No. 961, 2011 Annex 9: Model guidance for the storage and transport of time and temperature–sensitive pharmaceutical products
Các sản phẩm nhạy cảm với nhiệt độ như hóa chất, thịt, thực vật, thuốc và vắc-xin yêu cầu phải kiểm soát nhiệt độ từ khâu sản xuất đến tiêu dùng và mọi bước trung gian.
Tính nhất quán về nhiệt độ đảm bảo chất lượng của các sản phẩm này khi chúng di chuyển qua các chuỗi cung ứng tương ứng. Tuy nhiên, đảm bảo tính nhất quán nhiệt độ là một thách thức.
Xem thêm các tài liệu khác trên kênh của Công ty Cổ phần Tư vấn thiết kế GMP EU.
Temperature Sensor Calibration COVID-19 VaccinesAMETEK STC
For COVID-19 vaccines requiring ultra-low temperatures, maintaining freezing temperatures throughout the process, from manufacturing to delivery to patients, is necessary. Failure at any point to do so can result in wasted vaccines, which are so desperately needed. See how the JOFRA RTC-159 temperature calibrator can help ensure accuracy in the cold chain storage.
Nimble Wireless - Temperature Monitoring Solution for Medical AssetsNimble Wireless Inc
The objective of this primer is to provide the reader with an understanding of Medical Supply Chain Management. The challenges pharma companies face during logistics and storage of medical goods and how to overcome it.
Global regulatory agencies are pushing for comprehensive cold chain monitoring programs that extend from raw materials to distribution to patients. Proper validation and qualification of storage facilities has become necessary to demonstrate compliance with good manufacturing practices. Sensitech provides a variety of validation services including installation, operational, and performance qualification to ensure storage environments consistently meet acceptance criteria and protect product quality throughout the supply chain.
This document discusses the importance of maintaining proper cold chain management for pharmaceutical products, especially clinical trial materials. It covers definitions of active and passive cold chain systems, requirements for validation of cold chain processes, challenges in global clinical trials, and the roles of service providers and regulations. Proper cold chain is crucial for ensuring product quality and safety.
Thực phẩm dễ hỏng ngay cả khi chúng được tối ưu hóa trong việc chế biến và đóng gói. Chúng cần được phân phối và lưu trữ một cách thích hợp để đảm bảo chất lượng và thời hạn sử dụng của chúng. Các mặt hàng dễ hỏng như sữa, rau, trái cây, hải sản, thịt, đồ đông lạnh và các sản phẩm dược phẩm như thuốc, vắc-xin, thuốc tiêm, v.v. Những sản phẩm này rất nhạy cảm với nhiệt độ và hạn sử dụng của chúng bị ảnh hưởng nếu không được bảo quản phù hợp. Để đảm bảo điều đó, cần có các kho chuỗi lạnh hiệu quả - nơi có thể quản lý sản phẩm, đồng thời giảm hao hụt.
GSM technology is used to monitor the different parameters of an ICU patient remotely and also control over medicine dosage is provided. Measurements of vital signs and behavioral patterns can be translated into accurate predictors of health risk ,even at an early stage and can be combined with alarm triggering systems in order to initiate the appropriate actions. The conventional methods including wet adhesive Ag/AgCl electrodes for HR and HRV, the capnograph device for respiratory status and pulse oximetry for oxyhemoglobin saturation provide excellent signals but are expensive, troublesome and inconvenient. A method to monitor physiological information based on GSM offers a new means for health monitoring. In this paper, we review the latest developments in monitoring and discuss the challenges and future directions for this field.
This document compares the recent electronic Vaccine Intelligence Network (e-VIN) system to the old manual system for monitoring India's Universal Immunization Program in Jhalawar District, Rajasthan. The e-VIN system uses temperature loggers, mobile data entry, and online reporting to provide real-time vaccine storage temperature monitoring and inventory visibility. This allows for timely corrective action, optimized planning, and more effective management. In contrast, the old system relied on manual temperature recording, stock ledgers, and in-person monitoring, which was time-consuming and delayed decision making. User training and defined supervision were found to be important for high adoption rates and data quality with the new e-VIN system.
Streamlining Temperature Management: A Deep Dive into Data LoggersInfyiot Solutions
Temperature data loggers provide an accurate, continuous stream of temperature data that helps industries maintain precise temperature control and meet regulatory compliance. They enable real-time monitoring to prevent issues like product spoilage, and historical analysis of temperature trends for optimization. Industries such as food, pharmaceuticals, healthcare, and logistics benefit from the precision, reliability and insights temperature data loggers provide.
Monitoring Temperature Trends: The Power of Temperature Data LoggersInfyiot Solutions
In today’s interconnected world, where precise data drives decisions across various industries, the importance of monitoring temperature trends cannot be overstated. Whether you’re managing a pharmaceutical warehouse, operating a food production facility, or preserving artefacts in a museum, maintaining optimal temperature conditions is critical. This is where Temperature Data Logger steps in as an invaluable tool, offering real-time insights that help ensure quality, safety, and compliance.
Similar to Hdbs15, phụ lục 9 gmp who, hệ thống theo dõi nhiệt độ độ ẩm trong khi vận chuyển (19)
Quy trình kiểm soát thay đổi sau khi cấp Giấy chứng nhận GMP/Giấy chứng nhận đủ điều kiện kinh doanh dược đối với cơ sở sản xuất thuốc, nguyên liệu làm thuốc
Quy trình đánh giá đáp ứng “Thực hành tốt sản xuất thuốc, nguyên liệu làm thuốc” (GMP) đối với cơ sở không thuộc diện cấp chứng nhận đủ điều kiện kinh doanh dược
This document lists 46 consulting projects completed or in progress by GMPc Vietnam Joint Stock Company between May 2011 and January 2024. The projects involve consulting services for clients seeking to establish, expand, or renovate pharmaceutical manufacturing facilities that meet Good Manufacturing Practice (GMP) standards set by the World Health Organization (WHO) and other regulatory bodies. Services provided include facility design, budgeting, training on GMP requirements, and assistance with drafting and finalizing GMP registration dossiers. Clients span the pharmaceutical, biotech, and healthcare industries in Vietnam.
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These lecture slides, by Dr Sidra Arshad, offer a quick overview of the physiological basis of a normal electrocardiogram.
Learning objectives:
1. Define an electrocardiogram (ECG) and electrocardiography
2. Describe how dipoles generated by the heart produce the waveforms of the ECG
3. Describe the components of a normal electrocardiogram of a typical bipolar lead (limb II)
4. Differentiate between intervals and segments
5. Enlist some common indications for obtaining an ECG
6. Describe the flow of current around the heart during the cardiac cycle
7. Discuss the placement and polarity of the leads of electrocardiograph
8. Describe the normal electrocardiograms recorded from the limb leads and explain the physiological basis of the different records that are obtained
9. Define mean electrical vector (axis) of the heart and give the normal range
10. Define the mean QRS vector
11. Describe the axes of leads (hexagonal reference system)
12. Comprehend the vectorial analysis of the normal ECG
13. Determine the mean electrical axis of the ventricular QRS and appreciate the mean axis deviation
14. Explain the concepts of current of injury, J point, and their significance
Study Resources:
1. Chapter 11, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 9, Human Physiology - From Cells to Systems, Lauralee Sherwood, 9th edition
3. Chapter 29, Ganong’s Review of Medical Physiology, 26th edition
4. Electrocardiogram, StatPearls - https://www.ncbi.nlm.nih.gov/books/NBK549803/
5. ECG in Medical Practice by ABM Abdullah, 4th edition
6. Chapter 3, Cardiology Explained, https://www.ncbi.nlm.nih.gov/books/NBK2214/
7. ECG Basics, http://www.nataliescasebook.com/tag/e-c-g-basics
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These simplified slides by Dr. Sidra Arshad present an overview of the non-respiratory functions of the respiratory tract.
Learning objectives:
1. Enlist the non-respiratory functions of the respiratory tract
2. Briefly explain how these functions are carried out
3. Discuss the significance of dead space
4. Differentiate between minute ventilation and alveolar ventilation
5. Describe the cough and sneeze reflexes
Study Resources:
1. Chapter 39, Guyton and Hall Textbook of Medical Physiology, 14th edition
2. Chapter 34, Ganong’s Review of Medical Physiology, 26th edition
3. Chapter 17, Human Physiology by Lauralee Sherwood, 9th edition
4. Non-respiratory functions of the lungs https://academic.oup.com/bjaed/article/13/3/98/278874
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Title: Sense of Taste
Presenter: Dr. Faiza, Assistant Professor of Physiology
Qualifications:
MBBS (Best Graduate, AIMC Lahore)
FCPS Physiology
ICMT, CHPE, DHPE (STMU)
MPH (GC University, Faisalabad)
MBA (Virtual University of Pakistan)
Learning Objectives:
Describe the structure and function of taste buds.
Describe the relationship between the taste threshold and taste index of common substances.
Explain the chemical basis and signal transduction of taste perception for each type of primary taste sensation.
Recognize different abnormalities of taste perception and their causes.
Key Topics:
Significance of Taste Sensation:
Differentiation between pleasant and harmful food
Influence on behavior
Selection of food based on metabolic needs
Receptors of Taste:
Taste buds on the tongue
Influence of sense of smell, texture of food, and pain stimulation (e.g., by pepper)
Primary and Secondary Taste Sensations:
Primary taste sensations: Sweet, Sour, Salty, Bitter, Umami
Chemical basis and signal transduction mechanisms for each taste
Taste Threshold and Index:
Taste threshold values for Sweet (sucrose), Salty (NaCl), Sour (HCl), and Bitter (Quinine)
Taste index relationship: Inversely proportional to taste threshold
Taste Blindness:
Inability to taste certain substances, particularly thiourea compounds
Example: Phenylthiocarbamide
Structure and Function of Taste Buds:
Composition: Epithelial cells, Sustentacular/Supporting cells, Taste cells, Basal cells
Features: Taste pores, Taste hairs/microvilli, and Taste nerve fibers
Location of Taste Buds:
Found in papillae of the tongue (Fungiform, Circumvallate, Foliate)
Also present on the palate, tonsillar pillars, epiglottis, and proximal esophagus
Mechanism of Taste Stimulation:
Interaction of taste substances with receptors on microvilli
Signal transduction pathways for Umami, Sweet, Bitter, Sour, and Salty tastes
Taste Sensitivity and Adaptation:
Decrease in sensitivity with age
Rapid adaptation of taste sensation
Role of Saliva in Taste:
Dissolution of tastants to reach receptors
Washing away the stimulus
Taste Preferences and Aversions:
Mechanisms behind taste preference and aversion
Influence of receptors and neural pathways
Impact of Sensory Nerve Damage:
Degeneration of taste buds if the sensory nerve fiber is cut
Abnormalities of Taste Detection:
Conditions: Ageusia, Hypogeusia, Dysgeusia (parageusia)
Causes: Nerve damage, neurological disorders, infections, poor oral hygiene, adverse drug effects, deficiencies, aging, tobacco use, altered neurotransmitter levels
Neurotransmitters and Taste Threshold:
Effects of serotonin (5-HT) and norepinephrine (NE) on taste sensitivity
Supertasters:
25% of the population with heightened sensitivity to taste, especially bitterness
Increased number of fungiform papillae
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Health Organization be liable for damages arising from its use. The named authors alone are responsible for the views
expressed in this publication.
3. Technical Supplement: Temperature and humidity monitoring systems for transport operations 1
Acknowledgments
The authors of this document are Kevin O’Donnell, Exelsius Cold Chain Management
Consultancy and member of the United States Pharmacopeia Expert Committee on
Packaging, Storage & Distribution 2010-2015 cycle, Patrick McGrath, Berlinger USA, Dr
Umit Kartoglu, WHO Geneva, and Denis Maire, WHO Geneva.
4. Technical Supplement: Temperature and humidity monitoring systems for transport operations 2
Contents
Acknowledgments................................................................................................................................ 1
Contents................................................................................................................................................... 2
Abbreviations ........................................................................................................................................ 3
Glossary ................................................................................................................................................... 4
1. Introduction .................................................................................................................................. 8
1.1 Requirements...................................................................................................................................... 8
1.2 Objectives.............................................................................................................................................. 9
1.3 Target readership.............................................................................................................................. 9
2. Guidance .......................................................................................................................................10
2.1 Associated materials and equipment......................................................................................10
2.2 Temperature and humidity monitoring devices ................................................................10
2.2.1 Device types...........................................................................................................................................11
2.2.2 Data collection, storage and retrieval......................................................................................15
References ............................................................................................................................................16
Revision history..................................................................................................................................17
5. Technical Supplement: Temperature and humidity monitoring systems for transport operations 3
Abbreviations
CI Chemical Indicator
ETI Electronic Temperature Integrator
EDLM Electronic Data Logging Monitor
IATA International Air Transport Association
NIST National Institute of Standards and Technology (USA)
PDA Parenteral Drug Association
TTI Time-Temperature Integrator
TTSPP Time- and Temperature-Sensitive Pharmaceutical Product
URS User Requirements Specification
6. Technical Supplement: Temperature and humidity monitoring systems for transport operations 4
Glossary
3PL: Third party logistics provider: a firm that provides service to its customers of
outsourced (or "third party") logistics services for part, or all of their supply chain
management functions.
4PL: Fourth party logistics provider: a general contractor who manages other 3PLs,
truckers, forwarders, custom house agents, and others, essentially taking responsibility for
a complete logistics process for the customer.
Ancillary packaging components: Packaging elements used to protect the TTSPP and
support or enhance performance of the completed package. This may include retainers,
dunnage, secondary protective packaging, and temperature data logging devices.
Chemical indicators: (also called markers or phase-change indicators), are generally
impregnated onto a paperboard substrate. These indicators, sometimes referred to as
critical temperature indicators, are based on a phase change or chemical reaction that
occurs as a function of temperature. Examples include liquid crystals, waxes, polymers,
and lacquers that change phase, and thereby their appearance, as a function of
temperature. Threshold type chemical indicators are irreversible and are suitable for high
or low temperatures. Temperature threshold indicators show a response and typically are
single-use devices. These indicators provide a signal only when exposed to temperatures
higher than (ascending indicator) or lower than (descending indicator) a predetermined
threshold temperature. Progressive type chemical indicators register multiple events in a
cumulative way. As long as the device remains below the threshold temperature no
changes occur. However, whenever the threshold temperature is exceeded the reaction is
activated and the indicator starts to change. Further temperature violations increase the
change process. The indicator for this type of device usually takes the form of a
progressive colour change along a paper strip.
Critical Control Point (CCP): A step or procedure at which controls or checks can be
applied to prevent or reduce a hazard or risk to and acceptable or critical level. In the
context of distribution and handling of time and temperature-sensitive healthcare
products, critical control points are typically defined for those activities where time and
temperature abuse may occur or where critical processes that can affect the performance
of the packaging solution or containment system are at risk.
Electronic Data Integrator (EDI): A hybrid electronic instrument intelligently
programmed like an Electronic Temperature Indicator (ETI) with the report/data
producing capabilities of an Electronic Data Logging Monitor (EDLM) that combines the
features and functions of a Go/No-go device with the record retention and data tracking of
an EDLM. It uses pre-programmed temperature threshold intelligence to integrate post-
analytic functional steps that are typically performed by trained personnel.
Electronic Data Logging Monitor (EDLM): A small portable device that measures and
stores temperature at a pre-determined time intervals by means of an electronic sensor.
They have programmable alarm capabilities, integrated displays, and can create reports
and graphs which may be permanently stored, shared and analysed via proprietary
hardware, software, desktop application or through hosted databases.
Electronic Temperature Indicator (ETI): A compact, portable device that measures,
temperature over time by means of a built-in sensor. They come in a wide range of forms,
7. Technical Supplement: Temperature and humidity monitoring systems for transport operations 5
features, configurations, cost and levels of performance. Their composition consists of four
basic components: a thermistor sensor, a microprocessor, a memory chip, and power
source (lithium battery).
Electronic temperature monitoring and event logger system: System for recording
and reporting air and/or product temperatures, with optional facilities for recording and
reporting specific events such as door-opening or defrost cycles, and for issuing alarms.
Such systems may be user-programmable and may also be remotely monitored via a
satellite link.
External distribution: Transport of TTSPPs through various steps in the customer’s
supply chain (i.e. transport from a pharmaceutical manufacturer’s distribution centre, to
commercial customers (including wholesalers, retailers and buying groups), to clinical
facilities or direct to the patient). Contrast with internal distribution.
Humidity (Relative Humidity): The partial pressure of water vapour in air to the vapour
pressure of saturated air at a given temperature. In other words, the relative humidity is
the amount of water vapour present, divided by the theoretical amount of moisture that
could be held by that volume of air at a given temperature.
Internal distribution: Transport of a TTSPP within a pharmaceutical manufacturer’s
internal supply chain (i.e. all internal transport from the manufacturing plant to the
packaging plant and onwards to warehouses and distribution centres). Contrast with
external distribution.
Passive systems: Systems which maintain a temperature-controlled environment inside
an insulated enclosure, with or without thermostatic regulation, using a finite amount of
pre-conditioned coolant in the form of chilled or frozen gel packs, phase change materials,
dry ice or others.
Pharmaceutical product: Any product intended for human use or veterinary product
intended for administration to food producing animals, presented in its finished dosage
form, that is subject to control by pharmaceutical legislation in either the exporting or the
importing state and includes products for which a prescription is required, products
which may be sold to patients without a prescription, biologicals and vaccines. Medical
devices are not included1
.
Qualification: Action of proving that any premises, equipment and supporting systems
work correctly and actually lead to the expected results. The meaning of the word
validation is sometimes extended to incorporate the concept of qualification.
Refrigerated container or reefer: A thermally insulated shipping container or
intermodal freight container, equipped with an integrated refrigeration unit, used for the
transport of TTSPPs, by road, rail or ocean freight. The refrigeration unit requires an
external electrical power supply when located at a land based site, on a container ship or
on a quay. During road transport electrical power is typically supplied by a diesel
generator.
Refrigerated vehicle: Road transport vehicle such as a van, truck or semi-trailers whose
isolated thermostatically controlled cargo compartment is maintained at a temperature
1 Definition from WHO/QAS/08.252 Rev 1 Sept 2009. Proposal for revision of WHO good distribution
practices for pharmaceutical products – Draft for comments.
8. Technical Supplement: Temperature and humidity monitoring systems for transport operations 6
different (lower or higher) than the external ambient conditions. The environment inside
the cargo compartment may be temperature-controlled or temperature-modified.
Refrigeration equipment: The term ‘refrigeration’ or ‘refrigeration equipment’ means
any equipment whose purpose is to lower air and product temperatures and/or to control
relative humidity.
Service Level Agreement (SLA): A service level agreement or contract is a negotiated
agreement between the customer and service provider that defines the common
understanding about materials or service quality specifications, responsibilities,
guarantees and communication mechanisms. It can either be legally binding, or an
information agreement. The SLA may also specify the target and minimum level
performance, operation or other service attributes2
.
Shipping system: All components constituting a completed package including: the outer
shipping container, all internal ancillary packaging components and temperature
stabilizing medium.
Storage temperature: The temperature range listed on the TTSPP label, and within the
regulatory filings, for long-term storage.
Temperature excursion: An event in which a TTSPP is exposed to temperatures outside
the range(s) prescribed for storage and/or transport. Temperature ranges for storage and
transport may be the same or different; they are determined by the product manufacturer,
based on stability data.
Temperature stabilizing medium: Ice or gel packs; gel bricks, bottles or pouches; cool
water or warm water packs, phase change materials, dry ice, rapid evaporation media
which limit exposure of packed product to excessively high or low temperatures during
transport: also referred to as refrigerants or coolants.
Temperature-controlled: Includes any environment in which the temperature is actively
or passively controlled at a level different from that of the surrounding environment
within precise pre-defined limits.
Temperature-modified: Includes any environment in which the temperature is
predictably maintained at a level different from that of the surrounding environment, but
is not actively or passively controlled within precise predefined limits.
Thermistor: An electrical resistor whose resistance is greatly reduced by heating, used
for measurement and control.
Time and temperature sensitive pharmaceutical product (TTSPP): Any
pharmaceutical good or product which, when not stored or transported within pre-
defined environmental conditions and/or within pre-defined time limits, is degraded to
the extent that it no longer performs as originally intended.
Time-Temperature Integrators (TTI’s): Are generally chemically impregnated onto a
pulp or paperboard substrate. Their reaction rate or diffusion process is used to estimate a
temperature equivalent integrated over time. Thus, TTIs provide a measure of
accumulated heat rather than instantaneous temperature such as a spike or critical
threshold (see Chemical Indicators). The reactions are irreversible – once a colour change,
2 Definition from IATA. 2013/2014 Perishable Cargo Regulations (ePCR) & Temperature Control
Regulations (eTCR)
9. Technical Supplement: Temperature and humidity monitoring systems for transport operations 7
colour development, or diffusion process has taken place, exposure to low temperatures
will not restore the indicator to its original state. They change colour, or are marked by a
hue progression in intensity (generally from light to dark) in response to cumulative
changes in temperature, such as heat, at a rate dependent on the Arrhenius Equation. A
TTI accumulates all of the temperature conditions experienced by the product to which it
is affixed. The colour development can be customized based on the known stability of the
product, and in much the same way that most biologics and pharmaceuticals degrade
when exposed to heat - faster at higher temperatures, and slower at lower temperatures.
Transport temperature profile: Anticipated ambient temperature variation and
duration to which a TTSPP may be exposed during transport.
User Requirement Specification (URS): The attributes assigned by the user in advance
of a qualification test to establish minimum performance limits. Sometimes referred to as
a Functional Requirements Document.
Validation: Documented testing performed under highly controlled conditions,
demonstrating that processes, methods, and systems consistently produce results meeting
pre-determined acceptance criteria.3
3 PDA Technical Report No. 39: Guidance for Temperature Controlled Medicinal Products:
Maintaining the Quality of Temperature-Sensitive Medicinal Products through the Transportation
Environment, 2007.
10. Technical Supplement: Temperature and humidity monitoring systems for transport operations 8
1. Introduction
This technical supplement has been written to amplify the recommendations given in
Section 6.5 and Section 9 of WHO Technical Report Series No. 961, 2011, Annex 9: Model
guidance for the storage and transport of time- and temperature-sensitive pharmaceutical
products4.
The strength, efficacy, and potency of a drug can be profoundly degraded by changes in
temperature. Some products may also be affected by exposure to adverse humidity levels5.
It is not always possible completely to prevent degradation during transport, but damage
can be minimized through good handling and storage practices, by qualifying the mode
and route of transport, and by using qualified packaging.
For quality assurance purposes, stakeholders in the supply chain should be able to supply
documentary evidence that the pharmaceutical product has not exceeded the acceptable
limits of time, temperature and humidity exposure, as determined by the manufacturer’s
stability data for the product. This evidence is supplied by recording devices and
technologies that provide a history of exposure to temperatures and/or humidity during
transport and external distribution. It is important to bear in mind that humidity can only
be measured during transport; it cannot generally be controlled.
Effective temperature and humidity monitoring is an important component of Good
Distribution Practice (GDP) and can only be achieved if close attention is paid to the
relevant Critical Control Points.
The following Technical Supplements are also relevant:
Qualification of temperature-controlled road vehicles.
Qualification of shipping containers.
Transport route profiling qualification.
Temperature-controlled transport operations.
Temperature and humidity monitoring systems for fixed storage areas
1.1 Requirements
Generally speaking, the shipper is responsible for ensuring product temperature
compliance during transport. Shippers should operate under the terms of a formal Service
Level Agreement (SLA) with their carrier(s) or logistics service provider(s) i.e. freight-
forwarder, 3PL, 4PL or integrator. If shipping operations are carried out in-house, they
should be controlled by a comprehensive set of Standard Operating Procedures (SOPs).
SLAs and SOPs must clearly specify the types of temperature and humidity monitoring
device that are to be used, when and where they are to be employed, and how the data
they generate should be collected, reported and stored.
4 http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf
5 Note that it is generally considered that humidity exposure data has a minimal effect on drug
products that are in their original manufacturer’s packaging and further enclosed in an active or
passive shipping container. However, there may be some products for which this is an important
consideration. Card packaging and primary container labels can also be degraded by high levels of
humidity.
11. Technical Supplement: Temperature and humidity monitoring systems for transport operations 9
1.2 Objectives
The objective of the Technical Supplement is to provide:
A technical description of the device technologies used to record temperature and
humidity exposure during the transport life-cycle of a drug product.
A description of the documentary evidence that should be supplied to regulatory
authorities and other interested parties so that quality assurance and regulatory
compliance can be demonstrated and maintained.
1.3 Target readership
This supplement is intended for all those responsible for the transport of TTSPPs from one
fixed storage point to another in the supply chain. The target readership also includes
those responsible for providing evidence of temperature and humidity exposure during
this process. Monitoring temperatures in fixed storage locations is covered by the
companion Technical Supplement: Temperature and humidity monitoring systems for fixed
storage areas.
Staff responsible for transport operations need to have a good knowledge of the various
types of temperature and humidity monitoring device used in the transport environment,
together with their strengths, weaknesses and appropriate uses. They must also be
capable of operating, reading and interpreting data from these devices and must be
familiar with, and follow, good documentation practice.
12. Technical Supplement: Temperature and humidity monitoring systems for transport operations 10
2. Guidance
Temperature control during air, ocean or ground transport can be maintained using either
active or passive shipping systems. These systems are fully described in the companion
Technical Supplement: Temperature-controlled transport operations; this supplement
covers product packing, distribution and product off-loading for the following system
types:
Refrigerated and temperature-controlled vehicles;
Passive shipping systems;
Active shipping systems for air transport, and:
Active shipping systems for ocean transport.
The guidance below focuses on the selection and use of suitable temperature monitoring
devices for different legs (or stages) of the transport operation.
2.1 Associated materials and equipment
The key physical components of a quality-assured temperature-controlled transport
system are the active and passive packaging systems in which products are placed during
transport and the monitoring devices used to record temperature and humidity exposure
within these packaging systems. The specific characteristics of the operational
environments where these monitoring devices are used are described in the companion
Technical Supplement: Temperature-controlled transport operations.
2.2 Temperature and humidity monitoring devices
The main reason for choosing a temperature or humidity-monitoring device is to
determine whether or not the quality of a pharmaceutical product has potentially been
compromised as a result of exposure to harmful or unwanted conditions. The type of
technology and the device selected should be based on a user requirement specification
(URS).
Depending on the purpose defined in the URS, the selected device may serve as:
A device for determining acceptance or rejection of a shipment;
A post-use analytical tool for determining weakness in the transport system, for
carrying out a trend analysis, or for collecting performance data.
The level of detail provided by the available range of devices varies widely and is
dependent on the specific application and the technology used. This is a field in which
there is rapid technological development.
All monitoring systems must meet regulatory expectations and requirements and must
provide the evidence needed to demonstrate that the TTSPP has not been exposed to
adverse temperatures during storage or transport. When specified to do so, the system
must also be able to provide the temperature records needed for documentation purposes.
Single-use devices should be supplied with a manufacturer’s calibration certificate and the
certificate should cover the entire temperature range over which the device is designed to
be used. These devices cannot be re-calibrated. Multiple use devices should be calibrated
against a certified, traceable reference standard once a year, unless otherwise justified.
13. Technical Supplement: Temperature and humidity monitoring systems for transport operations 11
Calibration should demonstrate the accuracy of the unit across the entire temperature
range over which the device is designed to be used.
Whenever devices are selected it is essential to consider the needs of the specific
application, including ease of use and ease of integration across the supply chain. Some
devices require additional software or hardware, such as a docking station; this may not
be acceptable in certain use-cases. Whatever device or system is chosen, it should be
accurate, stable, reliable and validated.
2.2.1 Device types
The glossary gives a full definition of each of the temperature monitoring devices listed
below. Some of the more sophisticated electronic devices include humidity data collection.
However, it is generally considered that humidity exposure data has minimal adverse
effect on pharmaceutical products when they are in hermetically sealed primary
packaging and further enclosed in an active or passive shipping container.
Figure 1 shows examples of the following commonly used device types and Table 1
itemizes their features, benefits, limitations and proposed applications:
Chemical Indicators (CI) both threshold and progressive types and Chemical Time-
Temperature Integrators (CTTI).
Electronic Temperature Indicator (ETI).
Electronic Data Logging Monitors (EDLM).
Electronic Data Integrators (EDI).
Electronic temperature monitoring and event logger systems for refrigerated
vehicles (TMEL).
The accuracy and level of performance of these devices varies between manufacturers and
they should therefore be carefully selected to meet the specific URS.
Figure 1 – Examples of device types
Chemical Indicators (CI), Chemical Time-Temperature Integrators (CTTI)
CI: TempTime LIMITmarker™ device –
threshold indicator for high temperature
CI: Temptime FREEZEmarker®
14. Technical Supplement: Temperature and humidity monitoring systems for transport operations 12
CI: Cold Chain Monitor Card (progressive and
threshold types in one card)
CTTI: Vaccine Vial Monitor
Electronic Temperature Indicators (ETI)
Sensitech FreezeAlert™ Berlinger Q-tag®
Quad
LogTag TICT-iS0°Tag®
Electronic Data Logging Monitors (EDLM)
Libero data logger LogTag® TRIX-8 Temperature Recorder
Electronic Data Integrators (EDI)
Berlinger Q-Tag® CLm Doc LogTag® TIC20 VaxAlert™ Temperature
Indicator
15. Technical Supplement: Temperature and humidity monitoring systems for transport operations 13
Electronic temperature monitoring and event logger systems (TMEL)
Transcan Sentinel with thermal printer
16. Technical Supplement: Temperature and humidity monitoring systems for transport operations 14
Table 1 – Performance characteristics of monitoring devices
Fixed
TCI PCI
Provides go / no-go information at a glance ✔ ✔
Responds when a temperature threshold has been exceeded ✔ ✔ ✔
Responds to a single event ✔ ✔
Irreversable change ✔ ✔ ✔ ✔
Responds to a temperature equivalent integrated over time ✔
Responds as a result of a single and cumulative events ✔ ✔
Response occurs as a result of cumulative exposure ✔ ✔
Visual indication: color change, color development, diffusion, graphical
indication
✔ ✔ ✔ ✔
No additional equipment needed to read results ✔ ✔ ✔ ✔ 1 1 1
Accuracy of ±0.5 °C ✔ ✔ ✔ ✔
Multiple temperature alarm threshold capabilities ✔ ✔ ✔ ✔
Multiple time alarm threshold capabilities ✔ ✔ ✔ ✔
Alarm parameters programmable by manufacturer only ✔ ✔ ✔ ✔
Alarm parameters programmable by manufacturer or user ✔ ✔ ✔
Can be used as an analytical tool ✔ ✔ ✔ ✔
Capable of producing graphs, numerical data and summary reports 2
✔ ✔ ✔
Single use devices are calibrated by manufacturer prior to use ✔ ✔
Devices are individually serialized for traceability ✔3
✔3
✔3
✔ ✔ ✔ ✔
User activation required ✔ ✔ ✔ ✔ ✔
User deactivation required ✔ ✔ ✔
Accidental activation may occur if not properly stored/transported prior to
use ✔4
Monitoring upper and lower limits at the same time requires use of two
indicators
✔ ✔ ✔
Interpretation of color change may be affected by human factors ✔ ✔
Not an analytical tool ✔ ✔ ✔
Standard time and temperature limits (some customization available for high
volume applications)
✔ ✔ ✔ ✔
Single use device ✔ ✔ ✔ ✔
No time-specific traceability ✔ ✔ ✔ ✔
Requires regular calibration ✔ ✔5
✔
Temperature accuracy varies over operating range ✔ ✔ ✔ ✔
Recording frequency and recording time tied to size of device memory ✔ ✔
Additional proprietary hardware, software application or licensing may be
required for downloading data
2
✔ ✔
12-36 month battery life ✔6
✔ ✔ ✔
Requires professional installation ✔
Point-to-point distribution ✔ ✔ ✔ ✔ ✔ ✔
Entire life-cycle of drug ✔
Portable
FeaturesandbenefitsLimitationsUseage
CI
CTTI ETI EDLM EDI TMEL
5
Applies only to multiple use devices
6
Some devices have 5 year battery life
Key: CI: Chemical Indicator; TCI: Treshold Chemical Indicator; PCI: Progressive Chemical Indicator; CTTI: Chemical Time
Temperature Integrators; ETI: Electronic Temperature Indicator; EDLM: Electronic Data Logging Monitor; EDI: Electronic Data
Integrator; TMEL: Electronic temperature monitoring and event logger system.
1
Some versions of these devices have LCD screens where results can be read. However, for download, additional
equipment may be needed.
2
Some versions of these devices are downloadable and produce both graphs and detailed data sheets
3
These devices are serialized by lot, not individually
4
If devices are incorrectly packed during shipment from the supplier, the START button on some electronic devices may
inadvertently trigger activation. This is uncommon.
17. Technical Supplement: Temperature and humidity monitoring systems for transport operations 15
2.2.2 Data collection, storage and retrieval
Different devices generate different types and amounts of information. Devices, such as
EDLMs, that record time and temperature data that can be downloaded must be used to
produce this information in accordance with the relevant regulatory requirements for
documented data storage.
In most instance downloaded time and temperature data should be retained for at least
three years in a non-volatile format that enables the data to be retrieved. Suitable formats
include printed hard copies or a non-volatile and retrievable electronic medium such as a
computer hard drive, tape drive, flash drive or DVD. Storage in a secure web-based data
repository may also be acceptable.
Go/ No go data of the type supplied by CIs, CTTIs and ETIs should be recorded on the
appropriate product arrival report and this information should be used to make decisions
on whether to accept the TTSPP consignment into active storage at the receiving store, or
whether to quarantine it until an investigation has taken place and a final disposition has
been made.
18. Technical Supplement: Temperature and humidity monitoring systems for transport operations 16
References
Association Francaise du Froid. Practical Guidelines – Cold Chain for Medicines,
2009.
EN 12830:1999. Temperature recorders for the transport, storage and distribution
of chilled, frozen, deep-frozen/quick-frozen food and ice cream. Tests, performance
and suitability.
http://shop.bsigroup.com/en/ProductDetail/?pid=000000000019969694
IATA. 2013/2014 Perishable Cargo Regulations (ePCR) & Temperature Control
Regulations (eTCR)
http://www.iata.org/publications/Pages/temperature-control-regulations.aspx
PDA Technical Report No. 39 (revised 2007); Guidance for Temperature-Controlled
Medicinal Products: Maintaining the Quality of Temperature-Sensitive Medicinal
Products Through the Transportation Environment. Parenteral Drug Association,
2007.
https://store.pda.org/ProductCatalog/Product.aspx?ID=1270
US Food and Drug Administration. Title 21--Food and Drugs. Chapter I--Food and
Drug administration Department of Health and Human Services. Subchapter A—
General. Part 11 Electronic Records; Electronic Signatures 21 CFR Part 11
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/cfrsearch.cfm?cfrpart=
11.
USP <1079> Good storage and shipping practices for drug products. United States
Pharmacopeia. 2009.
https://mc.usp.org/sites/default/files/documents/GeneralChapterPDFs/c1079%
20USP36.pdf
USP <1118> Monitoring Devices–Time, Temperature, and Humidity. United States
Pharmacopeia, 2007.
http://www.pharmacopeia.cn/v29240/usp29nf24s0_c1118.html
WHO Technical Report Series No. 961, 2011, Annex 9: Model guidance for the
storage and transport of time- and temperature-sensitive pharmaceutical
http://apps.who.int/medicinedocs/documents/s18683en/s18683en.pdf
19. Technical Supplement: Temperature and humidity monitoring systems for transport 17
Revision history
Date Change summary Reason for change Approved